MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY, MAIH, 2.0 DIA, W/SWITCH, 100-120VONLY, PAKAG; INTERNAL PADDLE

Model Number 1011-0139-05

Device Problem Failure to Discharge (1169)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2015

Event Type  malfunction  

Event Description

Complainant alleged that while attempting to defibrillate a (b)(6), female pt, the internal handles would not allow the associated defibrillator to discharge.Complainant indicated that was no adverse effect to the pt due to the reported malfunction.

Manufacturer Narrative

Zoll medical corp has not received the product for evaluation and this complaint is still under investigation.

Manufacturer Narrative

The internal handles were returned to zoll medical corporation.The malfunction was duplicated and attributed to a faulty discharge switch.The handles were scrapped subsequent to testing.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: ASSY, MAIH, 2.0 DIA, W/SWITCH, 100-120VONLY, PAKAG
• Type of Device: INTERNAL PADDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 4805710
• MDR Text Key: 5833763
• Report Number: 1220908-2015-01308
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown,unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1011-0139-05
• Device Catalogue Number: 8011-0139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 62 YR